Protocol summary

Study aim
Effects of active cycle breathing technique on health status, sleep quality, and health-related quality of life of people with chronic obstructive pulmonary
Design
This study is a randomized, single-phase, and unblinded clinical trial.
Settings and conduct
This study is being conducted at the medical and educational centers of Shahrekord University of Medical Sciences, and due to the nature of the study, blinding was not performed.
Participants/Inclusion and exclusion criteria
Participants completed a written consent form to participate in the study. The age range of patients with chronic obstructive pulmonary disease was 20 to 70 years. The participants' disease was diagnosed by a pulmonologist and confirmed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, which are as follows: • Having symptoms of shortness of breath, cough, and increased sputum production or a history of exposure to risk factors • The ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) was less than 0.7 (FEV1/FVC ratio < 70%). (54, 55). The subjects were free of physical and mental problems that would interfere with the learning process. The subjects were free of severe respiratory problems and respiratory failure that would lead to intolerance to the breathing technique.
Intervention groups
The control group received only routine care, and the intervention group, in addition to receiving routine care, performed the active cycle breathing technique for 3 months, twice a day, for 15 to 20 minutes each time.
Main outcome variables
The effect of the active breathing cycle technique on sleep quality is measured using the Pittsburgh Sleep Quality Questionnaire, health-related quality of life with the St. George Questionnaire, and health status with the Chronic Obstructive Pulmonary Assessment Test (CAT) questionnaire.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240630062284N2
Registration date: 2025-12-06, 1404/09/15
Registration timing: prospective

Last update: 2025-12-06, 1404/09/15
Update count: 0
Registration date
2025-12-06, 1404/09/15
Registrant information
Name
Komeil Zamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 4013
Email address
komeilzamani20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-22, 1404/10/01
Expected recruitment end date
2026-03-11, 1404/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of active cycle breathing technique on health status, sleep quality, and health-related quality of life of people with chronic obstructive pulmonary disease
Public title
Effects of active cycle breathing technique on health status, sleep quality, and health-related quality of life of people with chronic obstructive pulmonary disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants complete written consent to participate in the study. The age range of patients with chronic obstructive pulmonary disease is 20 to 70 years. The participants' disease was diagnosed by pulmonology specialists and confirmed based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, which are as follows: • Having symptoms of shortness of breath, cough, and increased sputum production or a history of exposure to risk factors • The ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) should be less than 0.7 (FEV1/FVC ratio < 70%).
Exclusion criteria:
People with physical and mental problems that interfere with the learning process. People with severe respiratory problems and respiratory failure that lead to intolerance to the breathing technique
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning samples to groups will be in the form of random blocks with different numbers without permutation. For this purpose, first the letter A is considered for the control group and the letter B for the experimental group, and different states of the two groups will be written on the card, and each will be placed in a sealed and opaque envelope. To cover the assignment, blocks with different numbers will be used, that is, blocks of 6 and 2 will be included in the blocks. The block of 6 can be a combination of ABBABA and ... The block of 2 can also include AB, BA. These envelopes are placed in a box and the researcher will not know which group the units under study will be in until the card is selected. Before facing the research units, the ward nurse (unaware of the study and the groups) will determine which group the patients who will enter the study will be in, respectively, by removing one of the envelopes from the box. This process will continue until all the cards are removed from the box, and the cards will be returned to the box again, and this random selection will be repeated until the desired sample size is provided.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Shahrekord, Kashani Blvd., University Headquarters
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2025-11-10, 1404/08/19
Ethics committee reference number
IR.SKUMS.NUMHE.REC.1404.002

Health conditions studied

1

Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease

Primary outcomes

1

Description
Health status
Timepoint
before the start of the intervention, one week and 3 months after the start of the intervention
Method of measurement
The COPD Assessment Test (CAT)

2

Description
Sleep quality
Timepoint
before the start of the intervention, one week and 3 months after the start of the intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)

3

Description
Health-related quality of life
Timepoint
before the start of the intervention, one week and 3 months after the start of the intervention
Method of measurement
St George's Respiratory Questionnaire (SGRQ)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Perform the active cycle breathing technique independently and without supervision, twice a day (morning and evening), each time for 15 to 20 minutes (preferably before meals or 1 hour after) at home for 3 months. It includes rest periods between other parts of this cycle and continues until the person feels ready to perform other parts of the cycle or start a new cycle. By relaxing his shoulders and using the lower parts of the chest, the person tries to perform diaphragmatic breathing at a natural depth and speed. 2- Thoracic Expansion Exercises (TEE): In this stage, by increasing lung volume, air flow and clearing secretions from narrow airways and air diffusion in healthy lung parts are improved. To do this, the patient holds the air for 2 to 3 seconds by taking a deep and active breath and then exhales the air slowly and completely with a passive exhalation. This stage is performed following the BC stage and is repeated up to 3 times. 3- Forced expiratory technique (FET): This stage is a combination of one or two forced exhalations (huffs) along with the (BC) stage. By suddenly contracting the respiratory and abdominal muscles and huffing or coughing, the speed of air exiting the small airways increases and helps clear secretions.
Category
Rehabilitation

2

Description
Control group: Routine treatment and care methods will be used, and the researcher will not have any role in providing this training and care to this group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Nasser Khosravi
Street address
Parastar Street
City
Shahr-e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۴۶۳۳
Phone
+98 38 3110 7000
Email
Hajar-Hospital@skums.ac.ir

2

Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Mohammad Khaksar Baldaji
Street address
Parastar Street
City
Shahr-e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817758915
Phone
+98 38 3226 4841
Email
Kashani@skums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Jaefar Moghaddasi
Street address
Deputy of Research and Technology, Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 9509
Email
research@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Komeil Zamani
Position
Senior nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Deputy of Research and Technology, Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 9509
Email
komeilza50@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Jaefar Moghaddasi
Position
Assistant Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Deputy of Research and Technology, Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 9509
Email
jaefar_moghaddasi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Komeil Zamani
Position
Master's degree student in nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Deputy of Research and Technology, Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 9509
Email
komeilza50@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Biographical data such as age and gender are essential for better presentation of research results, and since this data is anonymous, there is no reason not to publish it.
When the data will become available and for how long
Due to the anonymity and coding of the data, they will be available after the study is completed.
To whom data/document is available
This data will be accessible to various health professionals and researchers.
Under which criteria data/document could be used
No analysis of this data is permitted and it will only be used for comparison with and citation of results from other studies
From where data/document is obtainable
The download of the resulting article will be done according to the policy of the journal that publishes it. Therefore, the use of biographical data tables and other sections of the journal is possible after downloading. The email address of the responsible author included in the article will be available for communication with other authors and for guidance.
What processes are involved for a request to access data/document
For this purpose, the applicant can contact the office of the journal that published the article, the corresponding author, and the Vice President for Research of Shahrekord University of Medical Sciences. The duration of access depends on the policy of the journal and the Vice President for Research of the university, but the corresponding author will respond to the request of colleagues within a week.
Comments
Loading...